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31 Diseases |  |
42 Trials |
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42 Trials |  |
576 News |  |
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- Mulpleta (lusutrombopag) / Shionogi, Doptelet (avatrombopag) / Dova Pharmaceuticals
UNCOVERING CLINICAL GAPS IN THE MANAGEMENT OF CHRONIC LIVER DISEASE-ASSOCIATED THROMBOCYTOPENIA IN ADULTS REQUIRING ELECTIVE INVASIVE PROCEDURES: A CLINICAL PRACTICE ASSESSMENT (Poster Exhibition - Hall 7) - Aug 18, 2019 - Abstract #UEGW2019UEGW_3280;
Whilst this highlights some of the key issues and challenges in current practice, and may reflect the current lack of access to and clinical experience with TPO-RA, this strongly points to a need for education to establish a better understanding of the impact of TPO-RA on practice. Clinicians require support with the implementation of the paradigm shift that is needed for effective and safe routine application of TPO-RA to achieve the best patient outcomes.
- | Mulpleta (lusutrombopag) / Shionogi, Doptelet (avatrombopag) / Dova Pharmaceuticals
Journal: Thrombocytopenia in Chronic Liver Disease and the Role of Thrombopoietin Agonists. (Pubmed Central) - Aug 9, 2019
A specific platelet count has not demonstrated a decreased bleeding rate in the periprocedural period in randomized, controlled trials, and using TPO agonists is not devoid of risk. However, the newly approved agents have shown no increase in the rate of portal vein thrombosis in this population and have shown promising results for increasing platelet counts.
- | Doptelet (avatrombopag) / Dova Pharmaceuticals
Clinical, P3 data, Journal: Phase 3 randomised study of avatrombopag, a novel thrombopoietin receptor agonist for the treatment of chronic immune thrombocytopenia. (Pubmed Central) - Jul 19, 2019
P3
The safety profile of avatrombopag was consistent with Phase 2 studies; the most common adverse events were headache and contusion. Overall, avatrombopag was well tolerated and efficacious for the treatment of chronic ITP.
- | Doptelet (avatrombopag) / SOBI
Clinical, P1 data, Journal: Avatrombopag, an oral thrombopoietin receptor agonist: results of two double-blind, dose-rising, placebo-controlled Phase 1 studies. (Pubmed Central) - Jul 19, 2019
Platelet count increases began 3-5 days post-administration, with maximum changes of >370 × 10 /l over baseline with 20 mg daily after 13-16 days. These data support continued development of avatrombopag for treatment of other thrombocytopenic conditions and provide important guidance for the haematologist in the use of this new thrombopoietin receptor agonist.
- | Doptelet (avatrombopag) / SOBI
Journal: Avatrombopag. (Pubmed Central) - Jul 17, 2019
These data support continued development of avatrombopag for treatment of other thrombocytopenic conditions and provide important guidance for the haematologist in the use of this new thrombopoietin receptor agonist. No abstract available
- | Nplate (romiplostim) / Amgen, Kyowa Hakko Kirin, Doptelet (avatrombopag) / SOBI, Promacta (eltrombopag) / Novartis
Clinical, Journal: Relative potency of the thrombopoietin receptor agonists eltrombopag, avatrombopag and romiplostim in a patient with chronic immune thrombocytopenia. (Pubmed Central) - Jul 11, 2019
No abstract available No abstract available
- || Doptelet (avatrombopag) / Dova Pharmaceuticals
FDA event: FDA Approves Avatrombopag in Chronic ITP https://t.co/aEqd7VgEnQ (Twitter) - Jul 6, 2019
- || Doptelet (avatrombopag) / Dova Pharmaceuticals
FDA event: WATCH: Dr. Fertrin on the @US_FDA Approval of Avatrombopag in ITP @UWMedicine https://t.co/8k7pxEuwcj (Twitter) - Jul 2, 2019
- || Doptelet (avatrombopag) / Dova Pharmaceuticals
FDA event: #ICYMI: FDA Approves Avatrombopag in Chronic ITP https://t.co/O4ZC5kWqNt (Twitter) - Jul 1, 2019
- | Doptelet (avatrombopag) / Dova Pharmaceuticals
PK/PD data, Journal: Pharmacokinetic/pharmacodynamic drug-drug interactions of avatrombopag when co-administered with dual or selective CYP2C9 and CYP3A interacting drugs. (Pubmed Central) - Jun 26, 2019
The results from co-administration of fluconazole or itraconazole suggest that CYP2C9 plays a predominant role in metabolic clearance of avatrombopag than CYP3A. To achieve comparable platelet count increases when avatrombopag is co-administered with CYP3A and CYP2C9 inhibitors, an adjustment in the dose or duration of treatment is recommended, while co-administration with strong inducers is not currently recommended.
- | Nplate (romiplostim) / Amgen, Kyowa Hakko Kirin, Doptelet (avatrombopag) / SOBI, Promacta (eltrombopag) / Novartis
Review, Journal: Optimal use of thrombopoietin receptor agonists in immune thrombocytopenia. (Pubmed Central) - Apr 23, 2019
Use of endogenous thrombopoietin levels to predict response to eltrombopag and romiplostim treatment is discussed and alternative dosing protocols suited for certain patient subgroups are described. Finally, indications for discontinuation and combination therapy with other agents are considered.
- | Doptelet (avatrombopag) / Dova Pharmaceuticals
Biomarker, Clinical, PK/PD data, Journal: Pharmacokinetics, Pharmacodynamics, Pharmacogenomics, Safety, and Tolerability of Avatrombopag in Healthy Japanese and White Subjects. (Pubmed Central) - Mar 29, 2019
No clinically important differences were found when avatrombopag pharmacokinetics and pharmacodynamics were compared between Japanese and white subjects. Administration of avatrombopag was generally well tolerated.
- | Doptelet (avatrombopag) / SOBI
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: Avatrombopag for the Treatment of Thrombocytopenia in Adults Scheduled for a Surgical Procedure (clinicaltrials.gov) - Mar 8, 2019
P3, N=4, Terminated, Sponsor: Dova Pharmaceuticals
Administration of avatrombopag was generally well tolerated. N=60 --> 4 | Trial completion date: Nov 2019 --> Feb 2019 | Recruiting --> Terminated | Trial primary completion date: Nov 2019 --> Feb 2019; Study was terminated due to enrollment challenges.
- Doptelet (avatrombopag) / SOBI
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: AVA-CLD-401: Avatrombopag for the Treatment of Thrombocytopenia in Adults With Chronic Liver Disease Undergoing a Procedure (clinicaltrials.gov) - Mar 8, 2019
P=N/A, N=50, Terminated, Sponsor: Dova Pharmaceuticals
N=60 --> 4 | Trial completion date: Nov 2019 --> Feb 2019 | Recruiting --> Terminated | Trial primary completion date: Nov 2019 --> Feb 2019; Study was terminated due to enrollment challenges. N=500 --> 50 | Trial completion date: Apr 2020 --> Jan 2019 | Recruiting --> Terminated | Trial primary completion date: Feb 2020 --> Jan 2019; Study was terminated early due to enrollment challenges
- ||| Doptelet (avatrombopag) / SOBI
New trial: AVA-CLD-401: Avatrombopag for the Treatment of Thrombocytopenia in Adults With Chronic Liver Disease Undergoing a Procedure (clinicaltrials.gov) - Jul 16, 2018
P=N/A, N=500, Recruiting, Sponsor: Dova Pharmaceuticals
- ||| Doptelet (avatrombopag) / SOBI
Enrollment open: AVA-CLD-401: Avatrombopag for the Treatment of Thrombocytopenia in Adults With Chronic Liver Disease Undergoing a Procedure (clinicaltrials.gov) - Jun 26, 2018
P=N/A, N=500, Recruiting, Sponsor: Dova Pharmaceuticals
N=500 --> 50 | Trial completion date: Apr 2020 --> Jan 2019 | Recruiting --> Terminated | Trial primary completion date: Feb 2020 --> Jan 2019; Study was terminated early due to enrollment challenges Not yet recruiting --> Recruiting
- |||| Doptelet (avatrombopag) / SOBI
Enrollment open: Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Active Non-Hematological Cancers (clinicaltrials.gov) - Jun 26, 2018
P3, N=120, Recruiting, Sponsor: Dova Pharmaceuticals
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | Doptelet (avatrombopag) / SOBI
New P3 trial: Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Active Non-Hematological Cancers (clinicaltrials.gov) - Mar 19, 2018
P3, N=120, Not yet recruiting, Sponsor: Dova Pharmaceuticals
- | Doptelet (avatrombopag) / SOBI
Enrollment open: Avatrombopag for the Treatment of Thrombocytopenia in Adults Scheduled for a Surgical Procedure (clinicaltrials.gov) - Dec 22, 2017
P3, N=60, Recruiting, Sponsor: Dova Pharmaceuticals
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | Doptelet (avatrombopag) / SOBI
New P3 trial: Avatrombopag for the Treatment of Thrombocytopenia in Adults Scheduled for a Surgical Procedure (clinicaltrials.gov) - Oct 31, 2017
P3, N=60, Not yet recruiting, Sponsor: Dova Pharmaceuticals
- ||||||| Doptelet (avatrombopag) / SOBI
Trial completion, Enrollment change: Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Undergoing an Elective Procedure (clinicaltrials.gov) - Jun 12, 2017
P3, N=204, Completed, Sponsor: Eisai Inc.
Not yet recruiting --> Recruiting Recruiting --> Completed | N=300 --> 204
- ||||||| Doptelet (avatrombopag) / SOBI
Trial completion, Enrollment change: Treatment of Thrombocytopenia in Patients With Chronic Liver DiseaseUndergoing an Elective Procedure (clinicaltrials.gov) - Apr 20, 2017
P3, N=231, Completed, Sponsor: Eisai Inc.
Recruiting --> Completed | N=300 --> 204 Recruiting --> Completed | N=300 --> 231
- | Doptelet (avatrombopag) / SOBI
Trial completion: Study to Assess Pharmacokinetic Drug-Drug Interaction Between Avatrombopag When Co-Administered With Fluconazole, Itraconazole, or Rifampin in Healthy Subjects (clinicaltrials.gov) - Jan 4, 2017
P1, N=48, Completed, Sponsor: Eisai Inc.
Recruiting --> Completed | N=300 --> 231 Recruiting --> Completed
- | Doptelet (avatrombopag) / SOBI
New P1 trial: Study to Assess Pharmacokinetic Drug-Drug Interaction Between Avatrombopag When Co-Administered With Fluconazole, Itraconazole, or Rifampin in Healthy Subjects (clinicaltrials.gov) - Jun 22, 2016
P1, N=48, Recruiting, Sponsor: Eisai Inc.
- |||| Doptelet (avatrombopag) / SOBI
Trial primary completion date: Treatment of Thrombocytopenia in Patients With Chronic Liver DiseaseUndergoing an Elective Procedure (clinicaltrials.gov) - Nov 5, 2015
P3, N=300, Recruiting, Sponsor: Eisai Inc.
Recruiting --> Completed Trial primary completion date: Jul 2015 --> Dec 2016
- | Doptelet (avatrombopag) / SOBI
Trial completion: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Once-daily Oral Avatrombopag in Japanese Subjects With Chronic Liver Diseases and Thrombocytopenia (clinicaltrials.gov) - Jun 22, 2015
P2, N=39, Completed, Sponsor: Eisai Co., Ltd.
Trial primary completion date: Jul 2015 --> Dec 2016 Active, not recruiting --> Completed
- | Doptelet (avatrombopag) / SOBI
Enrollment closed: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Once-daily Oral Avatrombopag in Japanese Subjects With Chronic Liver Diseases and Thrombocytopenia (clinicaltrials.gov) - Apr 29, 2015
P2, N=36, Active, not recruiting, Sponsor: Eisai Co., Ltd.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- |||| Doptelet (avatrombopag) / SOBI
Trial primary completion date: Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Undergoing an Elective Procedure (clinicaltrials.gov) - Apr 19, 2015
P3, N=300, Recruiting, Sponsor: Eisai Inc.
Recruiting --> Active, not recruiting Trial primary completion date: Jul 2015 --> Dec 2016
- | Doptelet (avatrombopag) / SOBI
Trial completion: A Five-Treatment-Period Study to Evaluate the Single-Dose Pharmacokinetics and Pharmacodynamics of Avatrombopag in Healthy Japanese and White Subjects (clinicaltrials.gov) - Dec 19, 2014
P1, N=48, Completed, Sponsor: Eisai Inc.
Trial primary completion date: Jul 2015 --> Dec 2016 Active, not recruiting --> Completed
- | Doptelet (avatrombopag) / SOBI
New P2 trial: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Once-daily Oral Avatrombopag in Japanese Subjects With Chronic Liver Diseases and Thrombocytopenia (clinicaltrials.gov) - Aug 29, 2014
P2, N=33, Recruiting, Sponsor: Eisai Co., Ltd.
- Doptelet (avatrombopag) / SOBI
Enrollment closed: A Five-Treatment-Period Study to Evaluate the Single-Dose Pharmacokinetics and Pharmacodynamics of Avatrombopag in Healthy Japanese and White Subjects (clinicaltrials.gov) - Jun 8, 2014
P1, N=48, Active, not recruiting, Sponsor: Eisai Inc.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- |||| Doptelet (avatrombopag) / SOBI
Trial completion: Chronic Hepatitis C Virus Related Thrombocytopenia to Evaluate the Effects of E5501 (clinicaltrials.gov) - Jun 5, 2014
P2, N=65, Completed, Sponsor: Eisai Inc.
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- Doptelet (avatrombopag) / SOBI
Enrollment open: A Five-Treatment-Period Study to Evaluate the Single-Dose Pharmacokinetics and Pharmacodynamics of Avatrombopag in Healthy Japanese and White Subjects (clinicaltrials.gov) - May 18, 2014
P1, N=48, Recruiting, Sponsor: Eisai Inc.
Active, not recruiting --> Completed Active, not recruiting --> Recruiting
- |||||| Doptelet (avatrombopag) / SOBI
Enrollment open: Treatment of Thrombocytopenia in Patients With Chronic Liver DiseaseUndergoing an Elective Procedure (clinicaltrials.gov) - Mar 30, 2014
P3, N=300, Recruiting, Sponsor: Eisai Inc.
Active, not recruiting --> Recruiting Not yet recruiting --> Recruiting
- || Doptelet (avatrombopag) / SOBI
Trial completion: Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults With Chronic Immune Thrombocytopenia (Amendment 02) (clinicaltrials.gov) - Mar 30, 2014
P3, N=49, Completed, Sponsor: Eisai Inc.
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- | Doptelet (avatrombopag) / SOBI
Trial completion: A Single-dose Study in Healthy Japanese Male Adults to Evaluate Pharmacokinetics and Pharmacodynamics of E5501 5 mg Tablet (Study E5501-J081-015) (clinicaltrials.gov) - Jan 30, 2014
P1, N=15, Completed, Sponsor: Eisai Co., Ltd.
Active, not recruiting --> Completed Active, not recruiting --> Completed
- |||||| Doptelet (avatrombopag) / SOBI
Enrollment open: Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Undergoing an Elective Procedure (clinicaltrials.gov) - Jan 16, 2014
P3, N=300, Recruiting, Sponsor: Eisai Inc.
Active, not recruiting --> Completed Not yet recruiting --> Recruiting
- | Doptelet (avatrombopag) / SOBI
New P1 trial: A Five-Treatment-Period Study to Evaluate the Single-Dose Pharmacokinetics and Pharmacodynamics of Avatrombopag in Healthy Japanese and White Subjects (clinicaltrials.gov) - Jan 15, 2014
P1, N=48, Active, not recruiting, Sponsor: Eisai Inc.
- |||||||||| Doptelet (avatrombopag) / SOBI
New P3 trial: Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Undergoing an Elective Procedure (clinicaltrials.gov) - Nov 3, 2013
P3, N=300, Recruiting, Sponsor: Eisai Inc.
- Doptelet (avatrombopag) / SOBI
Enrollment change: A Study in Healthy Subjects to Evaluate Bioavailability of 4 Formulations of E5501 (clinicaltrials.gov) - Oct 30, 2013
P1, N=28, Completed, Sponsor: Eisai Inc.
Not yet recruiting --> Recruiting N=23 --> 28
- Doptelet (avatrombopag) / SOBI, Promacta (eltrombopag) / Novartis
Trial termination: A Phase 3, Multicenter, Randomized, Double-blind,Active-controlled, Parallel-group Trial With an Open-labelExtension Phase to Evaluate the Efficacy and Safety of OralE5501 Versus Eltrombopag, in Adults With Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) (clinicaltrials.gov) - Oct 29, 2013
P3, N=24, Terminated, Sponsor: Eisai Inc.
N=23 --> 28 Recruiting --> Terminated; Study was terminated early due to significant enrollment challenges.
- | Doptelet (avatrombopag) / SOBI
Enrollment change: Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults With Chronic Immune Thrombocytopenia (Amendment 02) (clinicaltrials.gov) - Oct 29, 2013
P3, N=49, Completed, Sponsor: Eisai Inc.
Recruiting --> Terminated; Study was terminated early due to significant enrollment challenges. N=100 --> 49
- Doptelet (avatrombopag) / SOBI, Promacta (eltrombopag) / Novartis
Enrollment change: A Phase 3, Multicenter, Randomized, Double-blind,Active-controlled, Parallel-group Trial With an Open-labelExtension Phase to Evaluate the Efficacy and Safety of OralE5501 Versus Eltrombopag, in Adults With Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) (clinicaltrials.gov) - Oct 29, 2013
P3, N=24, Terminated, Sponsor: Eisai Inc.
N=100 --> 49 N=350 --> 24
- |||||||||| Doptelet (avatrombopag) / SOBI
New P3 trial: Treatment of Thrombocytopenia in Patients With Chronic Liver DiseaseUndergoing an Elective Procedure (clinicaltrials.gov) - Oct 28, 2013
P3, N=300, Recruiting, Sponsor: Eisai Inc.
- ||| Doptelet (avatrombopag) / SOBI
Enrollment change: Chronic Hepatitis C Virus Related Thrombocytopenia to Evaluate the Effects of E5501 (clinicaltrials.gov) - May 15, 2013
P2, N=65, Active, not recruiting, Sponsor: Eisai Inc.
N=350 --> 24 N=100 --> 65
- ||| Doptelet (avatrombopag) / SOBI
Enrollment closed: Chronic Hepatitis C Virus Related Thrombocytopenia to Evaluate the Effects of E5501 (clinicaltrials.gov) - May 15, 2013
P2, N=65, Active, not recruiting, Sponsor: Eisai Inc.
N=100 --> 65 Recruiting --> Active, not recruiting
- | Doptelet (avatrombopag) / SOBI
Trial completion: A Open-label, Three-period, Partial-replicate Design Study to Evaluate the Inter- and Intrasubject Variability of the Avatrombopag To-be-marketed Formulation Administered as Single Doses of 40 mg to Healthy Subjects Receiving a Low-fat Meal (clinicaltrials.gov) - May 12, 2013
P1, N=36, Completed, Sponsor: Eisai Inc.
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- | Doptelet (avatrombopag) / SOBI
New P1 trial: A Single-dose Study in Healthy Japanese Male Adults to Evaluate Pharmacokinetics and Pharmacodynamics of E5501 5 mg Tablet (Study E5501-J081-015) (clinicaltrials.gov) - Jan 22, 2013
P1, N=15, Completed, Sponsor: Eisai Co., Ltd.
- | Doptelet (avatrombopag) / SOBI
New P1 trial: A Open-label, Three-period, Partial-replicate Design Study to Evaluate the Inter- and Intrasubject Variability of the Avatrombopag To-be-marketed Formulation Administered as Single Doses of 40 mg to Healthy Subjects Receiving a Low-fat Meal (clinicaltrials.gov) - Jan 1, 2013
P1, N=36, Completed, Sponsor: Eisai Inc.
- | Doptelet (avatrombopag) / SOBI
Trial initiation date: Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults With Chronic Immune Thrombocytopenia (Amendment 02) (clinicaltrials.gov) - Nov 19, 2012
P3, N=49, Completed, Sponsor: Eisai Inc.
Active, not recruiting --> Completed Initiation date: Dec 2011 --> Mar 2012